Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx (NCT00004234) | Clinical Trial Compass
CompletedPhase 3
Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
CanadaStarted 1999-08-02
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy at different times of the day may affect the chance of developing side effects such as mucositis.
PURPOSE: Randomized phase III trial to compare the incidence of mucositis in patients who have cancer of the mouth, pharynx, or larynx, who are receiving radiation therapy in either the morning or afternoon.
Who can participate
Age range16 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, pharynx (oropharynx, hypopharynx, or nasopharynx), or larynx eligible for radical radiotherapy
* TX, T1-4, NX, N0-3, M0
* Directly visible area of mucosa including 2 or more protocol specified anatomical locations in the radical target volume
* At least 6 cm\^2 in area irrespective of shape
* No M1 disease
* Intention to deliver radiotherapy to a radical dose without chemotherapy
* May have had surgical resection of the primary or neck nodes
* Postoperative macroscopic or microscopic residual disease that is eligible for radical radiotherapy is allowed
* Patients with completely resected disease who are judged to be at high risk of relapse and who are eligible for radical radiotherapy are allowed
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin ≥ 10 g/dL
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* Must have normal sleeping habits (i.e., normal circadian rhythm)
* Must have had dental assessment and necessary prophylactic dental extractions carried out
* No connective tissue diseases (e.g., systemic lupus, scleroderma, mixed connective tissue disease, rheumatoid arthritis)
* No …